Division of Child and Adolescent Neuropsychiatry, Department of Public Health and Pediatric Science, University of Turin, Turin, Italy.
Evid Based Ment Health. 2018 Nov;21(4):e10. doi: 10.1136/ebmental-2018-300040. Epub 2018 Oct 23.
The systematic assessment of the efficacy and safety of psychiatric medications in children and adolescents started about 20 years ago. Since then, a considerable number of randomised clinical trials have been conducted, including also a series of publicly funded comparative effectiveness studies to evaluate the therapeutic benefit of medications relative to psychosocial interventions, alone or combined with medications. On the whole, these studies have been informative of the paediatric pharmacokinetics, efficacy and safety of the most commonly used psychotropics. As a consequence, a number of meta-analyses have been conducted that have documented both the benefits and harms of the most common medication groups, such as stimulants, antidepressants and antipsychotics. Evidence-based practice guidelines have been produced, and clinicians can now better estimate the therapeutic value and the risk of treatment, at least at the group mean level. However, most clinical trials have been conducted in research settings, and this limits the generalisability of the results. There is a need for evaluating treatment effects under usual practice conditions, through practical trials. The ongoing debate about the proper role of pharmacotherapy in child mental health can be advanced by comparative effectiveness research to assess the benefit/risk ratio of pharmacotherapy vis-à-vis alternative treatment modalities. In addition, analyses of large population databases can better inform on the impact of early treatment on important distal outcomes, such as interpersonal functioning, social and occupational status, quality of life and risk for disability or mortality. Thus far, paediatric psychopharmacology has been mostly the application to children of medications that were serendipitously discovered and developed for adults. By focusing on the neurobiological mechanisms of child psychopathology, it may be possible to identify more precise pharmacological targets and arrive at a truly developmental psychopharmacology.
儿童和青少年精神药物疗效和安全性的系统评估大约始于 20 年前。从那时起，已经进行了相当数量的随机临床试验，包括一系列公共资助的比较疗效研究，以评估药物相对于心理社会干预的治疗效益，单独或与药物联合使用。总的来说，这些研究提供了关于儿科药代动力学、最常用精神药物疗效和安全性的信息。因此，进行了一些荟萃分析，记录了最常见药物组（如兴奋剂、抗抑郁药和抗精神病药）的益处和危害。已经制定了循证实践指南，临床医生现在可以更好地估计治疗的价值和风险，至少在群体平均水平上。然而，大多数临床试验都是在研究环境中进行的，这限制了结果的普遍性。需要通过实际试验在常规实践条件下评估治疗效果。通过比较疗效研究，可以推进关于精神药理学在儿童心理健康中适当作用的争论，以评估药物治疗相对于替代治疗方式的获益/风险比。此外，对大型人群数据库的分析可以更好地了解早期治疗对重要的远端结果（如人际关系功能、社会和职业地位、生活质量以及残疾或死亡的风险）的影响。到目前为止，儿科精神药理学主要是将偶然发现和开发用于成人的药物应用于儿童。通过关注儿童精神病理学的神经生物学机制，可能有可能确定更精确的药理学靶点，并实现真正的发展性精神药理学。
